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Incidence and Risk Factors for Hospitalization-Associated Disability

Incidence and Risk Factors for Hospitalization-Associated Disability (HAD) and Its Association With Hospital and Care Processes in Patients With Valvular Heart Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02572999
Enrollment
80
Registered
2015-10-09
Start date
2015-10-31
Completion date
2016-12-31
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Decline, Hospitalization-associated Disability, Iatrogenic Disease

Keywords

Aged, Frail, Functional decline, Impairment, valvular heart disease, Cohort, risk factors

Brief summary

This prospective cohort study aims to determine the incidence of hospitalization-associated disability and its association with risk factors at the patient level and with care and hospital processes. For this, patients aged 70 years or older admitted for elective valve surgery or elective transcatheter aortic valve implantation or as a result of symptomatic moderate to severe valvular heart disease will be consecutively included from 01 October 2015 to 29 February 2016.

Interventions

PROCEDURENot applicable (observational design)

Sponsors

KU Leuven
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Aged 70 years or older * Admitted for elective heart valve surgery (replacement, repair or combined with CABG) or if admitted for elective transcatheter aortic valve implantation, or if a patient presents with symptomatic moderate to severe valvular heart disease on hospital admission as evidenced by moderate to severe valve regurgitation (≥ 2/4) or aortic valve area ≤ 1cm2 or mitral valve area ≤ 1.5cm2 and if one of the following symptoms is present: heart failure, decreased exercise tolerance, (exertional) dyspnea, (exertional) angina, (exertional) syncope * Dutch speaking

Exclusion criteria

* Life expectancy less than 6 months * Expected length of stay less than 48 hours

Design outcomes

Primary

MeasureTime frameDescription
Hospitalization-associated DisabilityUp to 30 days post-hospital dischargeThe loss of ability to complete one of the basic ADLs independently between baseline and hospital discharge.

Secondary

MeasureTime frameDescription
Five meter gait speed testUp to 30 days post-hospital discharge
Timed get-up and go testUp to 30 days post-hospital discharge
The six minutes walking distance testUp to 30 days post-hospital discharge
Peak handgrip force assessed at the dominant side with the elbow at 90° of flexion, and the forearm and wrist in a neutral position.Up to 30 days post-hospital dischargeIsometric handgrip force will be measured with a hydraulic hand dynamometer (Jamar dynamometer; JA Preston Corporation; Jackson, MI)
Inappropriate medication prescribingUp to 30 days post-hospital dischargeInappropriate medication prescribing using the RASP-list (Rationalization of Home Medication by an Adjusted STOPP list in Older Patients)
Peak extension torque measured at the right side and evaluated at 60° of knee flexionUp to 30 days post-hospital dischargeIsometric quadriceps strength will be measured using a dynamometer (Biodex system 4 pro; Enraf Nonius; Delft, The Netherlands)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026